Prosthetic Foot + Physical Therapy for Leg Amputation

(OPORP Trial)

This trial aims to identify the best combination of prosthetic foot and physical therapy to enhance mobility and satisfaction for individuals who have lost a lower leg. Participants will test various prosthetic feet and select their favorites based on comfort and performance. They will then either continue with regular care or undergo an eight-week personalized physical therapy program using their chosen foot. Suitable candidates for this trial have lost one lower leg below the knee, have used a prosthetic for at least six months, and can walk safely. As an unphased trial, this study allows participants to directly influence future prosthetic and therapy options.

The trial information does not specify whether you need to stop taking your current medications.

Research has shown that using a prosthetic foot with personalized physical therapy is generally safe for individuals who have lost a lower limb. Although specific safety data for using both together is lacking, studies on similar prosthetic devices have demonstrated benefits such as improved walking, increased safety, and enhanced comfort.

The selection of a prosthetic foot depends on what feels best to the user. Participants can choose from several options, often resulting in greater satisfaction and easier movement due to increased comfort with their choice. Additionally, personalized physical therapy aims to improve balance and movement, helping users feel more confident and safe.

Researchers are excited about this trial because it explores a personalized approach to prosthetic foot prescriptions combined with targeted physical therapy for individuals with leg amputations. Unlike standard prosthetics, which are often one-size-fits-all, this approach allows participants to experience walking with different prosthetic conditions and choose what works best for them. Additionally, the trial integrates an eight-week personalized physical therapy intervention, which could enhance rehabilitation outcomes beyond traditional methods. This combination aims to improve comfort, mobility, and overall quality of life for amputees, potentially setting a new standard in personalized prosthetic care.

Research has shown that customizing prosthetic feet can enhance mobility and satisfaction for individuals with lower limb loss. One study found that a prosthetic foot emulator allows patients to try different prosthetic feet before making a choice, leading to better decisions and outcomes. In this trial, participants will walk with three prosthesis conditions and select their most and least preferred. Past patients have demonstrated significant improvements in movement and balance with personalized foot selection and physical therapy. Another study found that individuals with below-the-knee amputations benefit greatly from specific rehabilitation programs, which enhance their ability to use prosthetics effectively. In this trial, participants will receive either the standard-of-care intervention or an eight-week personalized physical therapy intervention. These findings support tailoring both the prosthetic foot and therapy to individual needs for improved satisfaction and function.²⁴⁶⁷⁸